Archive for December, 2010

FDA issues warning about sexual enhancement drinks

The Food and Drug Administration on Thursday advised consumers not to buy or use two drinks sold as supplements for sexual enhancement. The products, Rock Hard Extreme and Passion Coffee, are sold on websites and possibly in retail outlets, the agency said. Laboratory analysis indicated that both contain sulfoaildenafil, an active pharmaceutical ingredient that is similar to sildenafil, the active ingredient in Viagra.

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FDA Issues Serious Recall of Balloon Catheters

The FDA upgraded a recall of aortic balloon catheters to class I — the agency’s most serious — due to the device potentially becoming jammed in its sheath. The recall affects the Arrow Ultra 8 Intra-Aortic Balloon Catheter 8 FR 30 CC and 40 CC and the Arrow Intra-Aortic Balloon Catheter with a Fiber Optic Sensor and Measurement System. If the device gets stuck in its sheath, the user will be unable to move it forward or backward, delaying therapy, causing bleeding, or injury to an artery, an FDA statement said.

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Cumberland Pharmaceuticals Announces Voluntary Recall of Acetadote(R) Vials…

Cumberland Pharmaceuticals Inc. announced today that it has implemented a recall of 6 lots of Acetadote(R) (acetylcysteine) Injection, the Company’s injectable treatment to prevent or lessen liver injury after ingestion of a potentially toxic quantity of acetaminophen. Cumberland informed the U.S. Food and Drug Administration (FDA) of its plans to voluntarily recall these lots of Acetadote as a precautionary measure based on observed particulate matter found in a very small number of vials.

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DePuy’s Hip Replacement: The New Big Thing in Product Liability Suits?

Many patients who have received the Articular Surface Replacement, a hip replacement device made by DePuy Orthopaedics, claim to have developed curious pain, and surgeons who have replaced the implant say they have found mysterious masses of dead tissue near patients’ thighs. Some patients allege that they have high levels of cobalt ions in their blood, prompting them to fear they risk poisoning themselves.

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Abbott Labs Recalls 359 Million Glucose Test Strips

Abbott Laboratories is recalling as many as 359 million glucose test strips because they may incorrectly show low blood-sugar levels, U.S. regulators said. The false readings result from a manufacturing defect that prevents the test strips from absorbing enough blood, the Food and Drug Administration said today in a statement. Patients with diabetes who use the strips may fail to treat elevated blood glucose because of a false reading, or may try to raise their blood sugar unnecessarily, the agency said.

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Lipitor Recall Grows by 19,000 Bottles

The Lipitor recall continues with Pfizer’s recall of 19,000 more bottles of the popular cholesterol drug. A musty smell has led to four recalls, totaling 345,000 bottles since August 2010. The latest recall is dated Dec. 17 on Pfizer’s web site. The 19,000 bottles represent a single lot of Lipitor. Pfizer says one customer complaint spurred recall of the entire lot.

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FDA: Don’t Swallow Benadryl Gel

In May 2010 the FDA warned people about potentially serious side effects from mistakenly swallowing Benadryl Extra Strength Itch Stopping Gel, an over-the-counter (OTC) product that should only be used on the skin. The FDA has received reports of serious side effects in people who have mistakenly swallowed the product.

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